Purdue Pharma settlements a window into U.S. opioid crisis

The DePaulia | October 21, 2019

After more than 2,600 lawsuits nationwide involving their role in the opioid epidemic sweeping through the country, Purdue Pharma — the manufacturer of prescription painkiller OxyContin — filed for bankruptcy Sept. 16. In 2017, opioids were responsible for 47,600 of the 70,237 U.S. drug overdose deaths — with more than 28,000 of these opioid-related deaths being attributed to synthetic opioids, such as fentanyl. From 1999 to 2017, more than 400,000 Americans have died from opioid overdoses. The declaration of bankruptcy followed a tentative $10 to $12 billion settlement with 27 states and thousands of cities and counties throughout the nation — with nearly 20 other states rejecting the terms of the settlement. Dr. Richard Blondell, physician and vice chair for addiction medicine at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, said the company’s heavy marketing downplaying the addictive nature of OxyContin helped start the epidemic. “They promoted this drug heavily,” Blondell said. “I can remember representatives coming around with little bags, pens and clocks. They had a clock that just had 12 on there to remind us to prescribe it every 12 hours. The older physicians said, ‘Boy don’t listen to them. They don’t know what they’re talking about, these are addictive drugs,’ — and it turns out those old, family doctors were right.” Dr. Steven Aks, immersive physician and head of toxicology at Cook County Health, said it’s important to distinguish that there are two “faces” to the current opioid epidemic: pharmaceutical pills and street drugs.

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Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation | December 28, 2021

Envista Holdings Corporation announced that the U.S. Food and Drug Administration has cleared the Nobel Biocare N1™ implant system. Boasting a biologically driven design of components and forward-thinking treatment protocols, the N1™ implant system represents a significant step forward in patient-centric implant solutions. More than an implant, N1 is a comprehensive system of dedicated instruments, prosthetic components, and surgical protocols. New features of the system include an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance. Innovative site preparation for greater patient comfort The Nobel Biocare N1™ system includes the novel feature of the OsseoShaper™, an instrument that redefines site preparation and is set to reshape implantology with optimized workflows, greater patient comfort and faster treatment times. By gently 'shaping' the osteotomy at low speed and without irrigation, the OsseoShaper™ reduces noise and vibration compared to conventional drilling protocols. This leads to improved patient comfort and has been shown in pre-clinical studies to preserve vital bone. Embracing surface chemistry and digital workflows Fully embracing the new Mucointegration™ concept, the Nobel Biocare N1™ features the Xeal™ and TiUltra™ surface treatments. With their specially tailored surface chemistry and topography, TiUltra implants and Xeal abutments can benefit from this design to optimize tissue integration at every level. Nobel Biocare N1™ will be further integrated into the digital workflow with the DTX Studio™ suite, giving dental professionals more opportunities to provide patients with shorter time to teeth. "For over 50 years, Nobel Biocare has been a pioneering force behind implantology. The demand for high quality patient-centric solutions is higher than ever, and the Nobel Biocare N1™ system enables clinicians to set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can offer patients." Amir Aghdaei, Chief Executive Officer, Envista Patrik Eriksson, President Nobel Biocare, explained, "Drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper™ provides a completely new approach designed for patient comfort, streamlined workflow, and improved predictability; while at the same time, respects biology to achieve fast osseointegration. We are excited to partner with clinicians to bring the N1 system to US-based patients." About Nobel Biocare Nobel Biocare is a world leader in the field of innovative implant-based dental restorations. The company's portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems (including key brands NobelActive® and NobelParallel™ and ceramic implant NobelPearl™*) a comprehensive range of high-precision individualized prosthetics and CAD/CAM systems (NobelProcera®), digital solutions for treatment planning and guided surgery (NobelClinician® and DTX Studio™ suite) as well as biomaterials. Nobel Biocare supports its customers through all phases of professional development, offering world-class training and education along with practice support and patient information materials. The company is headquartered in Zurich, Switzerland. Production takes place at five sites located in the United States, Sweden, and Germany. Products and services are available in over 80 countries through subsidiaries and distributors. *Distributed by Nobel Biocare. Manufactured by Dentalpoint AG About Envista Envista is a global family of more than 30 trusted dental brands, including KaVo, Kerr, Nobel Biocare, and Ormco, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry.

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SurGenTec Launches ION Screw, Smallest Posterior Spinal Fixation Implant, to Market After Receiving FDA Clearance

SurGenTec® | March 03, 2022

SurGenTec®, a privately held spine and orthopedic technology company based in Boca Raton, FL, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for ION™ Screw, its proprietary stand-alone spine fixation implant. This unique device can be used to treat a variety of pathologies throughout the spine from C2-S1. The patented ION implant is the smallest posterior fixation implant cleared for spine surgery – smaller than the size of a dime – and can be placed through a tiny incision with minimal tissue disruption. ION screws are enhanced with Nanotex™ surface technology designed with bony interdigitation in mind. ION provides patients with a treatment option between conservative care and major interbody fusion in the algorithm of care. “The ION screw technology truly changes the game for spine surgery. Patients are looking for options outside traditional bulky metallic devices such as pedicle screws and interspinous plates. This minimally invasive option provides excellent fixation with zero profile. It’s a non-intimidating solution for patients that need to undergo a spine surgery procedure. We are thrilled to announce the addition of ION to our portfolio. Our team has put years into pre-clinical research and development to create this truly novel spinal fixation option. Our team managed to create a ‘micro’ implant with a unique surface technology that provides fixation without the need for cumbersome implants,” added Greenhalgh. Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec ION can be used in a variety of open or true minimally invasive surgery (MIS) applications including facet fusions, adjunct to decompressive procedures, the treatment of adjacent level disease or to provide added stability with interbody fusions. The ION facet screw system instruments were designed to minimize tissue trauma and incision size while delivering the ION implants to the surgical location. "The ION system is a great fit for the ambulatory surgery center environment by providing a cost-effective solution for physicians looking to minimize trauma while still providing a high level of spinal care to patients. Patients are demanding access to a more efficient operating environment with less risk of illness and disease transmission," said Andrew Shoup, Chief Operating Officer of SurGenTec. “ION represents a tremendous paradigm shift in the ability to treat my patients suffering from chronic degenerative lumbar conditions more definitively and less invasively,” said Dawood Sayed M.D., Division Chief and Professor of Anesthesiology and Pain Medicine at The University of Kansas Medical Center in reference to the recent FDA cleared ION facet screw system. “Traditionally, our patients with chronic back pain from lumbar degenerative disc disease, spondylosis, and spondylolisthesis are offered temporary relief with injections and ablations or invasive open surgical procedures. ION bridges an important gap for patients and physicians seeking less invasive options for these debilitating conditions. I am very honored to be amongst the first in the world to offer this remarkable treatment at our medical center,” continued Sayed. Unlike other spinal fixation options, the ION has zero profile above the bone which may prevent soft tissue contact and the potential for irritation. The implants may be packed with bone graft prior to and after insertion to help facilitate fusion while providing an opportunity for bone to bridge over the implant and prevent implant migration. “Using the ION system was intuitive and safe. It allowed me to provide a less invasive solution than I would have typically provided. The standard of care is changing, and ION offers a simple solution to advanced spinal conditions,” said Dr. Raphael Roybal M.D., orthopedic spine surgeon Coral Gables, FL. SurGenTec is a privately owned medical device company based in Boca Raton, Florida that is focused on unique technologies for the orthopedic and spine fields. SurGenTec develops and manufactures innovative products with patient and surgeon safety in mind. SurGenTec looks to launch ION immediately, with plans in the future of obtaining CE mark to market overseas. The vast pipeline of unique implants, instruments, biologics and ancillary solutions will continue to develop through a high level of internal research and development. SurGenTec currently has multiple products lines to market which are sold within the US and internationally. In 2018 and 2020, SurGenTec received the Spine Technology Awards for their ALARA™ target needle system and 3D Graftrasp presented at NASS.

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AbCellera and Empirico Expand Strategic Multi-Target Antibody Discovery Collaboration

AbCellera | May 04, 2022

AbCellera and Empirico Inc. announced today that they have expanded their strategic multi-target discovery collaboration, which leverages Empirico’s Precision Insights PlatformTM to discover genetically validated drug targets and AbCellera’s technology to identify lead candidate antibodies against those targets. Following the rapid progress of their first collaborative program, which identified a lead candidate against an undisclosed G protein-coupled receptor target in less than 12 months, the companies have expanded their partnership to include seven targets. In addition, under the expanded agreement, AbCellera has a co-development option on a program-by-program basis. Empirico’s platform is designed to uncover causal relationships between genes, proteins, and clinical outcomes by integrating genetic data and health information from millions of individuals together with experimental validation. AbCellera integrates leading technologies to solve all steps in the antibody discovery process and delivers to partners diverse and developable lead candidates against drug targets. “We have been impressed by Empirico’s ability to discover and validate new drug targets and believe the combination of our respective technologies has great potential to bring new first-in-class treatments to patients. We are pleased to build on our productive collaboration with Empirico by expanding the number of targets and maximizing the opportunity for mutual success by having an option to co-invest on a program-by-program basis.” Carl Hansen, Ph.D., CEO and President of AbCellera “AbCellera’s technology enables us to extend our competitive advantage in target discovery and validation with best-in-class antibodies to rapidly advance our programs towards the clinic,” said Omri Gottesman, M.D., CEO and President of Empirico. “We are excited to expand our relationship with AbCellera and to translate many more genetically validated targets into potential new antibody-based therapies together.” Under the terms of the expanded agreement, Empirico will have the right to develop and commercialize therapeutic antibodies resulting from the collaboration, and AbCellera has the option to co-develop each therapeutic program to maintain up to a 50 percent ownership stake. Financial terms were not disclosed. About Empirico Inc. Empirico is a next-generation therapeutics company founded on utilizing human genetics, data science, and programmable biology to power novel target discovery and development. Empirico’s Precision Insights PlatformTM, a proprietary human genetics-focused discovery platform, leverages a world-leading dataset, hyperscale infrastructure and algorithmic approaches that encode and enhance human intuition to identify and prioritize therapeutic targets. All potential therapeutic targets are subjected to rigorous in vitro and in vivo experimental validation to elucidate the mechanism by which genetic variation impacts disease risk and provide insights about which therapeutic modality could be ‘programmed’ to mimic or interfere with that mechanism. Empirico is advancing multiple programs across a broad range of indications and therapeutic modalities, both independently and in collaboration with industry partners. Empirico is headquartered in San Diego, California with laboratories in Madison, Wisconsin. About AbCellera Biologics Inc. AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.

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NextRNA Launches with $56 Million in Funding to Bring Transformative Non-Coding RNA-Directed Medicines to Patients

NextRNA Therapeutics | March 02, 2022

NextRNA Therapeutics, a biotechnology company unlocking the potential of non-coding RNAs to develop transformative therapeutics, announces its launch with $9.3 million in seed financing and a $46.8 million Series A led by Cobro Ventures and Lightchain Capital, with additional participation from Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors. Proceeds will be used by the company to augment its target and drug discovery engine, expand its pipeline, and advance lead programs. The vast majority of DNA is copied into RNAs that do not make proteins. These RNA molecules, called “non-coding RNAs,” play essential roles in cells by interacting with and modulating the activities of proteins. These interactions can drive pathogenic processes in multiple disease areas, including oncology, immunology, and neurology. Non-coding RNAs, in particular long non-coding RNAs, and their interacting proteins therefore represent a vast and untapped class of novel therapeutic targets. “NextRNA is uniquely positioned to be the leader in non-coding RNA-directed medicines. We have established a robust target and drug discovery engine to systematically identify disease-relevant long non-coding RNAs and their interacting proteins. By developing selective small molecules to drug these interactions, we plan to translate discoveries of non-coding RNA targets into a robust pipeline of transformative therapies across multiple disease areas.” Dominique Verhelle, Ph.D., MBA, co-founder, chief scientific officer, and interim chief executive officer, NextRNA NextRNA was established based on pioneering work by Carl Novina, M.D., Ph.D., at Dana-Farber Cancer Institute. “By understanding the interactions between long non-coding RNAs and specific proteins, we can decode the function of long non-coding RNAs and apply it to create medicines,” said Dr. Novina, co-founder of NextRNA. Since its founding in January of 2021, NextRNA has established its initial team, built out the target and drug discovery engine, and advanced two small molecule programs in oncology and immunology. “NextRNA is at the forefront of innovation in the field of non-coding RNAs,” said Todd Kaloudis, Managing Director at Cobro Ventures. “There is growing excitement around the potential of non-coding RNA-directed medicines, and we are pleased to have such an experienced team focused on NextRNA’s vision of bringing transformative therapies to patients.” About NextRNA Therapeutics NextRNA is a biotechnology company with a mission to translate pioneering science into transformative therapeutics for the benefit of patients. The company is leveraging its proprietary technology platform to systematically identify disease-relevant non-coding RNAs and their interacting proteins, and to develop selective small molecules to drug these interactions. NextRNA investors include Cobro Ventures, Lightchain Capital, Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors.

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